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Human Genome Sciences and GlaxoSmithKline Announce Topline Results from Pivotal Phase 3 Study of BENLYSTA in Systemic Lupus Erythematosus

Strategic Insights

— 1 min read

Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). BENLYSTA 10 mg/kg already met its primary efficacy endpoint at Week 52 in both BLISS-52 and BLISS-76, as announced in July and November 2009. At Week 76 in the BLISS-76 study, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by the SLE Responder Index; however, this secondary endpoint did not reach statistical significance.

Key Takeaways:

  • BENLYSTA (belimumab) 10 mg/kg met its primary efficacy endpoint at Week 52 in both BLISS-52 and BLISS-76 studies.
  • The secondary endpoint of the SLE Responder Index at Week 76 showed higher response rates for belimumab plus standard of care vs. placebo plus standard of care, but did not reach statistical significance.
  • Belimumab was generally well tolerated, with similar rates of discontinuations due to adverse events across treatment groups and comparable adverse event rates.
  • The data from the BLISS-76 study support a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions.
  • Belimumab is an investigational drug being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006.
  • Key findings from BLISS-76 provide additional evidence of the beneficial effect of belimumab.

Statistics:

  • Over 50% of patients with lupus have gone without an approved disease-modifying treatment for more than 50 years.
  • 38.5% of patients receiving belimumab 10 mg/kg plus standard of care achieved a response at Week 76, as measured by the SLE Responder Index.
  • 39.1% of patients receiving belimumab 1 mg/kg plus standard of care achieved a response at Week 76, as measured by the SLE Responder Index.
  • 32.4% of patients receiving placebo plus standard of care achieved a response at Week 76, as measured by the SLE Responder Index.

Sources:

  • Human Genome Sciences, Inc.
  • GlaxoSmithKline PLC
  • Clinical Trials Week via NewsRx.com

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